1. Field of the Invention
The invention relates to nutritional supplements and more particularly to a composition and method for reducing the risks associated with bone density loss, e.g., the risks of osteoporosis.
2. Description of Related Art
Osteoporosis is a debilitating disease affecting as many as one in three women after menopause. The disease affects the skeletal structure making the skeletal structure weak and frail. Calcium and magnesium supplementation is seen as one way to protect against osteoporosis. Men also experience a loss in bone density with age. Accordingly, health care practitioners increasingly encourage calcium and magnesium supplementation for men and women of all ages.
In general, only about 30 percent of dietary calcium is absorbed by the body and deposited in the bone. Improved calcium (and magnesium) absorption in the body would have important consequences in the reduction of osteoporosis and bone fractures.
Several calcium and/or magnesium supplements have been introduced in recent years. U.S. Pat. No. 5,389,387 issued to Zuniga, et al. and U.S. Pat. No. 5,401,524 issued to Burkes, et al. describe a calcium beverage supplement composition. These compositions combine malic acid and citric acid with a calcium syrup such as calcium lactate. The malic acid and citric acid provide stability against precipitation of the calcium salt, as well as taste and mouth feel quality. U.S. Pat. No. 5,424,321 issued to Shlyankevich and U.S. Pat. No. 5,654,011 issued to Jackson, et al. describe beverage compositions including calcium, Vitamin D, magnesium, and zinc.
Soy isoflavones are another group of dietary acceptable compounds believed to be beneficial in the treatment and/or prevention of osteoporosis. U.S. Pat. No. 5,424,321 describes a composition for the treatment or prevention of osteoporosis that utilizes soy bean food products that contain natural phytoestrogens of the isoflavone or coumestan groups. The isoflavones include daidzein, genistein, and glycitein. The classes of isoflavones can also be derived synthetically. The patent claims that the soy isoflavones are effective in preventing osteoporosis by provoking an estrogenic response in post-menopausal women.
In general, it is believed that the majority of calcium and magnesium absorption occurs in the intestines. Certain oligosaccharides, including inulin, are believed to stimulate mineral absorption in humans. Oligosaccharides are also believed to increase the bifidobacteria population in the large intestine including the colon, contributing to beneficial effects in humans, including a reduction of harmful bacteria, toxic metabolites, and detrimental enzymes.
What is needed is a composition that improves the calcium and magnesium absorption in humans to increase bone density and reduce the risk of osteoporosis.
An improved supplement composition and a method of reducing bone density loss is disclosed. In one aspect, a composition suitable for human consumption combines a dietary acceptable amount of a calcium compound, a dietary acceptable amount of a magnesium compound, at least one soy isoflavone, inulin, and a dietary acceptable amount of Vitamin D3. Other components, include but are not limited to, minerals such as phosphorus and zinc; vitamins including Vitamin C (ascorbic acid) and Vitamin K; stabilizing agents; acidifiers; and sweeteners.
The composition of the invention may be in the form of a ready to drink beverage, a beverage preparation of a dry mix or syrup concentrate, a wafer, a paste, or a bar. The composition may also contain a variety of levels of the individual components. For example, a desired daily amount of the individual components of the composition has been determined. This amount may be administered as a single dose or as several doses. Where the composition is a beverage, for example, the beverage may constitute, for example, one-eighth of a predetermined daily amount of the individual components, making the beverage suitable for consumption eight times daily as in the recommended daily amount of water intake.
In a beverage form, the invention maximizes the solubility of soy isoflavones in solution by, in one embodiment, including a stabilizing agent of at least one of maltol, a composition of carrageenan and maltodextrin, or xanthan gum. The beverage composition may be a clear or a colored solution without significant residue or sediment. The beverage is also, preferably, adjusted to a pH between 3 and 7 and more preferably between pH 4 and 5 at room temperature with an organic acid in an amount up to the equivalent amount of a calcium of the calcium compound.
As a method of reducing the risk of bone density loss, the invention contemplates the step of administering a composition suitable for human consumption comprising a portion of the daily predetermined amount of a calcium compound, a magnesium compound, an isoflavone, inulin, phosphorus, Vitamin D3, Vitamin K, a zinc compound, and ascorbic acid. The composition may be administered in various forms, including as a beverage, a paste, or a bar. The amount of the individual components of the composition may be adjusted to provide a portion, including the entire portion, of a predetermined beneficial amount, such as a predetermined daily amount.
The invention relates to a composition that includes a supplement to provide the dietary needs of individuals for nutrients to support adequate bone density and a healthy skeletal system. The composition also provides appropriate nutrients to reduce the risk of osteoporosis or to treat bone density loss associated with osteoporosis. The invention also relates to a method of reducing the risk of bone density loss commonly associated with the development or onset of osteoporosis.
In one embodiment, the composition of the invention comprises active ingredients of inulin, isoflavones such as soy isoflavones, minerals, and optionally one or more vitamins. More particularly, the composition includes, in one embodiment, a dietary acceptable amount of a calcium compound and a magnesium compound, together with a soy isoflavone, inulin, and a dietary acceptable amount of Vitamin D3.
Calcium and magnesium are important in supporting a healthy skeleton system, by building bone mass. There are a variety of calcium and magnesium salts that are suitable for human consumption and are suitable for contributing to bone growth according to the invention. Suitable calcium salts include, but are not limited to, calcium lactate and calcium gluconate. Suitable magnesium salts include, but are not limited to, magnesium glycerophosphate and magnesium sulfate. Magnesium glycerophosphate is a desired choice of the magnesium salt because magnesium glycerophosphate also contributes a phosphorous component to the composition. Phosphorous is believed to contribute to bone density and a healthy skeletal system.
Isoflavones are a dietary source for increasing bone density. The isoflavones suitable for the invention include, but are not limited to, the naturally occurring soy isoflavones from soy including the classes such as daidzein, genistein, and glycitein in a variety of forms (e.g., glycosidic and acetylated forms). Soy isoflavones are commercially available, for example, from Archer Daniels Midland of Decatur, Ill. Synthetically derived isoflavones may also be suitable.
Oligasaccharides include, but are not limited to, fructo-oligosaccharides and gluco-oligosaccharides. Inulin, a fructo-oligosaccharide is derived principally from chickory root. Oligosaccharides such as inulin provide at least two benefits. First, oligosaccharides increase the intestinal absorption of minerals, such as calcium and magnesium. Second, oligosaccharides improve the intestinal microflora by increasing the amount of colonic bifidobacteria. Inulin as an oligosaccharide source is commercially available, for example, from Imperial Suiker Unier of Sugar Land, Tex.
Vitamin D3 stimulates intestinal absorption of minerals, particularly calcium, and calcium mobilization. Cold water soluble (CWS) Vitamin D3 (cholecalciferol) is available commercially as from BASF Corporation of Paramus, N.J., or Hoffmann-La Roche of Nutley, N.J.
In addition to the above components, the composition of the invention may also include, but is not limited to, additional minerals such as phosphorous and zinc. Phosphorous, as noted above, promotes bone density. Zinc may be added, in particular, to offset any impact on zinc absorption caused by calcium uptake. Vitamins including Vitamin C (ascorbic acid) and Vitamin K (phylloquinone) may also be added to the composition of the invention. Vitamin C helps utilize the absorbed calcium and maintains normal calcium crystals in bones. Vitamin K is believed to reduce the urinary excretion of calcium and the production of bone resorbing agents such as prostaglandin E2 or interleukin 6. Additional components such as stabilizing agents, acidifiers, and sweeteners may further be added.
The composition of the invention can take many forms. These forms include, a ready-to-drink beverage of a portion, including the entire portion, of the predetermined requirements (e.g., predetermined daily requirements) for maximizing the intake and utilization of bone building (e.g., bone density promoting) materials such as calcium, magnesium, and isoflavone. The invention may also take the form of a beverage preparation of, for example, a dry mix or a concentrate syrup to be mixed with a liquid such as water, milk, or juice. In this manner, a more concentrated form of the composition of the invention may be packaged to be diluted with a liquid. Still further, the composition of the invention may take the form of a paste that may be spread on a wafer such as a sweet wafer (e.g., cookie) or a cracker. Yet further, a composition of the invention may be encompassed in the form of a bar. It is to be appreciated that in these other forms (e.g., paste, bar, etc.), the invention may constitute the entire portion of a predetermined amount (e.g., predetermined daily amount) of the components or a smaller portion of such predetermined amount. Still further, it should be appreciated that other forms of the composition may be contemplated without deviating from the spirit and scope of the invention. For example, dietary forms such as cereals or candies may also be utilized.
In one embodiment, the composition is a beverage comprising the entire portion or a smaller portion of the daily predetermined quantity of the desired components of the composition for increasing bone density and/or reducing the risk of osteoporosis.
In particular, the composition of a beverage comprises, in one example, a portion of the individual components corresponding to a predetermined daily amount dosage recommending eight servings per day. In this example, eight servings are chosen with the objective that an ordinary person will take around eight 240 mL dosages daily.
Table 1 represents a suitable range of the daily amount of individual components of the composition of the invention.
In one embodiment, the composition as a beverage includes a stabilizing agent to facilitate the solubilization of the individual components in solution. The stabilizing agent is one or more of a maltol commercially available from Cultor Food Science, Inc. of Ardsley, N.Y. A composition of carrageenan and maltodextrin such as sold under the trademark INSTA*THICK C-15L(trademark) by Zumbro Inc. of Hayfield, Minn., or a xanthan gum such as sold under the trademark KELTROL(trademark), by NutraSweet Kelco Company of Deerfield, Ill. Preferably, a composition is combined with a combination of maltol and a composition of carrageenan and maltodextrin or a composition of maltol and xanthan gum(s). In this manner, the solubility of the individual components of the composition, particularly soy isoflavones, is improved. A suitable range of maltol in the beverage composition of the invention is 0.1 g to 0.4 g for a 240 mL composition. The level of 0.1 g in 240 mL aqueous solution was found to increase the solubility of soy isoflavones in aqueous solution. A suitable range of a composition of carrageenan and maltodextrin commercially available under the trademark INSTA*THICK is 1.0 g to 4.0 g for a 240 mL composition. The level of 1 g in 240 mL water was found to increase the solubility of soy isoflavones in aqueous solution. A suitable range of xanthan gum commercially available under the trademark KELTROL-T is 0.024 g to 0.096 g for a 240 mL composition. The level of 0.024 g in 240 mL aqueous solution generally does not create a viscous mouthfeel. The 0.096 usage level is used in the preparation of 4xc3x97 concentrated syrup.
Table 2 shows the combination of maltol and INSTA*THICK C-15L(trademark) increases the solubility of three soy isoflavones, particularly genistin ( greater than 75%), in aqueous solution as assayed by high performance liquid chromatography. Microfiltration through a membrane with pore size from 0.45 to 1.2 xcexcm resulted in clarified solutions with less precipitation compared with non-microfiltered ones as shown in Table 3.
Different levels of sweeteners (such as, but not limited to, sugars, sugar alcohols, monosaccharides, disaccharides, trisaccharides) and different flavors may be used in the beverage product. The composition can be formed as a low calorie composition with artificial sweeteners such as, but not limited to, ASPARTAME(trademark), ACESULFAME-K(trademark), SACCHARIN(trademark), or SUCRALOSE(trademark) or any combination of the above. Appropriate flavors include, but are not limited to, orange, peach, cranberry, tangerine, raspberry, grapefruit, mango, black cherry, strawberry, or any combination of the above flavors. The beverage may be clear, colorless, translucent, and/or contain a colorant. Suitable colorants can be from natural sources or from certified FandDC colorants.
In one embodiment, the flavor characteristics are selected for optimum compatibility with other ingredients, particularly inulin, soy isoflavone, vitamins and minerals, to achieve a superior taste profile.
The composition, in one embodiment, is adjusted to be at a pH less than 7, and preferably between 3 and 7, and more preferably between 4 and 5. The addition of an acidifier such as a combination of malic acid and citric acid to one embodiment of the composition is utilized to adjust the pH from about 4 to about 7 (preferably below 4.6) and to overcome precipitation problems associated with prior art compositions. The pH of the beverage product between 4 and 5 is suitable because inulin is stable in solution above pH 4 at room temperature. Also, this medium-high acid (i.e., pH less than 4.6) of the beverage is desirable for bacterial control.
A preferred approximate ratio of calcium compound, magnesium compound, soy isoflavones, and the oligosaccharide inulin relative to one another is shown in Table 4.
Representative compositions of suitable beverages are provided. In the following ranges, the lower value represents a 240 mL composition containing one-eighth of a preferred predetermined dosage level and the upper value is a 4xc3x97 concentrate of a preferred predetermined dosage level comprises:
(a) about 0.26 to 8.33% (w/v) of inulin in a soluble form;
(b) about 0.0052 to 0.166 ppm (w/v) of Vitamin D3 as cholecalciferol;
(c) about 0.0026 to 0.083% (w/v) of soy isoflavones from concentrated extracts;
(d) about 0.026 to 0.83% (w/v) of calcium in a biologically acceptable soluble calcium salts, preferably calcium lactate;
(e) about 0.0052 to 0.166% (w/v) of magnesium in a biologically acceptable soluble magnesium salts, preferably magnesium glycerophosphate;
(f) about 2.08 ppm to 66.67 ppm (w/v) of zinc in a biologically acceptable soluble zinc salts, preferably zinc citrate;
(g) about 0.018 ppm to 0.58 ppm (w/v) of Vitamin K blend (1% phylloquinone);
(h) about 0.01 to 0.417% (w/v) of ascorbic acid;
(i) about 0.0052 to 0.166% (w/v) of maltol and 0.052 to 1.67% (w/v) of Insta*Thick C-15L (containing carrageenan and maltodextrin) from Zumbro Inc., or about 0.0052 to 0.166% (w/v) of maltol and about 12.5 ppm to 400 ppm (w/v) of xanthan gums;
The following examples describe methods for preparing a beverage composition of the invention as a single strength (comprising, in this example, the daily predetermined amounts of the individual components) or as a beverage preparation in the form of a concentrate syrup (3xc3x97 to 4xc3x97 the daily predetermined amount).